CRA (Level II)
CRA (Level II)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA) critical thinking and problem-solving skills to identify site processes failure andcorrective/preventiveactions to bring the site into compliance and decrease risks.
Ensures data accuracy through SDR SDV and CRF review as applicable through on-site and remote monitoring activities.
Assess investigational product through physical inventory and records review.
Documents observations in reports and letters in a timely manner using approved business writing standards.
Brings up observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed that previously identified issues are being resolved and that the data is being recorded in a timely manner.
Conducts monitoring tasks in accordance with the approved monitoring plan.
Participates in the investigator payment process.
Ensures a shared responsibility with other project team members on issues/findings resolution.
Investigates and follows-up on findings as applicable
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System CTMS).
Performs QC check of reports generated from CTMS system where required.
Participates in investigator meetings as necessary.
Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Gives to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review newsletter creation lead CRA team calls etc).
Facilitates effective communication between investigative sites the client company and the PPD project team through written oral and/or electronic contacts.
Responds to company client and applicable regulatoryrequirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Gives to other project work and initiatives for process improvement as required.
Employment Type
Full-Time
